Dry Eye
Conditions
Brief summary
The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe dry eye disease .
Detailed description
A multicenter,randomized, double-blind, vehicle-controlled Study.Subjects will be randomly assigned to the experimental group and the control group,experimental group: CsA eye gel: 0.3 g: 0.15 mg, once daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a day Control group: vehicle. One drop into the eye, once daily;One drop into each eye when you use it.hypromellose eye drops:10ml：50mg,three times a day
Interventions
The CsA eye gel of 0.3 g: 0.15 mg
DRUGPlacebo
Placebo
DRUGHypromellose Eye Drop
Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop
Sponsors
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1）18≤Age≤80, both male and female 2）According to the symptoms and signs and ophthalmologic examinations, the patients were diagnosed as moderate to severe dry eye 1. EDS score is more than 40 points; 2. BUT is less than 10 s; 3. Schirmer test result is less than 10mm/5 min; 4. ICSS≥2 points. 3）The ICSS score of baseline decreased by≤ 20% compared with that of screening period 4）Agree to participate in the study and voluntarily sign informed consent.
Exclusion criteria
1. Severe dry eye patients requiring surgical treatment 2. Had inner eye surgery within 12 months prior to screening or required inner eye surgery during the study period;Eyelid surgery was performed within 6 months prior to screening 3. Patients receiving permanent lacrimal insertion or patients receiving temporary lacrimal insertion within 6 months prior to screening; 4. Operation-induced dry eye 5. Glaucoma patients; 6. Unwilling to avoid wearing contact lenses; 7. Systemic inflammation or active eye infection and blepharitis; 8. Patients with multiple episodes of viral keratitis 9. Patients with ocular cicatricial pemphigoid, obvious conjunctival scar, ocular chemical burn and neurotrophic keratoconjunctivitis 10. Patients with malignant tumors in the past 5 years, except the thoroughly cured basal cell carcinoma of skin, squamous cell carcinoma in situ of skin, and primordial cervical cancer; 11. Perimenopausal women are taking hormone replacement therapy 12. Patients who cannot stop using other eye drops and other ophthalmic preparations during the study period; 13. Patients with severe cardiopulmonary diseases, uncontrolled hypertension and diabetes, etc. that affect the collection or compliance of study parameters; 14. ALT and AST ≥ 2 times of the normal upper limit, and serum creatinine ≥ 1.5 times of the normal upper limit 15. With a history of central nervous system disease or epilepsy, and/or a mental state that does not cooperate 16. Pregnant women and lactating women, or women of childbearing age, do not adopt effective contraceptive measures; 17. Participated in other clinical trials or participated in other clinical trials within 1 months before the election; 18. Systemic or topical cyclosporine drugs within 1 months before the election; 19. Allergy to CsA, fluorescein or any component of the drug is known； 20. Patients who were not considered suitable for the study, including those who were unable or unwilling to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients whose corneal fluorescein staining score (ICSS) decreased by ≥1 point from baseline at visit 5 (study eye) | 84 days after admission | ICSS：no staining = 0，few/rare punctate lesions = 1，discrete and countable lesions = 2，lesions too numerous to count，but not coalescent = 3，coalescent = 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average changes in VAS scores of 6 dry eye symptoms (burning/needling sensation, pruritus, foreign body sensation, discomfort, photophobia and pain) at the NO.3, NO.4 and NO.5 visit were compared with baseline (binocular) | 14 days after admission ，42 days after admission ，84days days after admission | 0-100 points VAS score was evaluated |
| corneal fluorescein staining score (ICSS)at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular) | 14 days after admission ，42 days after admission ，84days days after admission | ICSS：no staining = 0，few/rare punctate lesions = 1，discrete and countable lesions = 2，lesions too numerous to count，but not coalescent = 3，coalescent = 4 |
| EDS score at the NO.3, NO.4 and NO.5 visit was compared with the baseline EDS score (binocular) | 14 days after admission ，42 days after admission ，84days days after admission | 0-100 points VAS score was evaluated |
| Tear break-up time(BUT) at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular) | 14 days after admission，42 days after admission ，84days days after admission | The time taken for the first dry spot to appear on the cornea after a complete blink with fluorescein |
| Schirmer's II test (with anesthetic) at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular) | 14 days after admission ，42 days after admission ，84days days after admission | Basal tear secretion with topical anesthesia, determined by the moisture length on the filter paper in 5 minutes |
| oxford score at the NO.3, NO.4 and NO.5 visit was compared with the baseline (binocular) | 14 days after admission ，42 days after admission ，84days days after admission | 0\ V grade was evaluated |
Countries
China
Outcome results
None listed